BEDFORD, Mass.--(BUSINESS WIRE)--May 9, 2017--
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company
focused on the development, manufacturing and commercialization of
innovative therapies for diseases and conditions of the eye, today
presented data from preclinical studies evaluating the efficacy,
tolerability and pharmacokinetics of its sustained release intravitreal
tyrosine kinase inhibitor (TKI) depot (OTX-TKI) using the Company’s
proprietary bioresorbable hydrogel fiber technology at the Association
for Research in Vision and Ophthalmology (ARVO) Annual Meeting in
Baltimore, MD.

Tyrosine kinase inhibitors have shown promise in the treatment of wet
age-related macular degeneration (AMD). However, attempts to administer
topical or systemic TKIs for AMD have been limited by bioavailability
and off-target effects.

In this study, the OTX-TKI investigational drug product was
well-tolerated, and high tissue levels of TKI were maintained for up to
6 months in Dutch belted rabbits. For the first time, the ability to
deliver an efficacious dose of TKI to the posterior segment of the eye
for the treatment of VEGF-induced retinal leakage was demonstrated for
an extended duration of up to six months.

“These preclinical studies of OTX-TKI have demonstrated the ability to
deliver and maintain high therapeutic tissue levels of TKI in the
vitreous humor, retina and choroid,” said Jonathan H. Talamo, M.D.,
Chief Medical Officer of Ocular Therapeutix. “With these positive
results from our preclinical studies, we are looking forward to
beginning our Phase 1 trial of OTX-TKI later this year.”

Four posters evaluating the OTX-TKIdepotwere presented
at the ARVO Annual Meeting:

The pharmacokinetics over 6 months of sustained delivery from the
OTX-TKI depot placed by intravitreal injection in Dutch belted rabbits
were evaluated. OTX-TKI produced significant and increasing levels of
TKI in the vitreous humor, retina and choroid at months 1 through 6
without clinical evidence of local toxicity. Plasma levels were below
the level of quantification, suggesting minimal risk of systemic
toxicity.

The efficacy over 6 months of sustained delivery of an OTX-TKI depot
placed via intravitreal injection was investigated in a Dutch belted
rabbit, vascular endothelial growth factor (VEGF) induced, retinal
leakage model. Eyes were challenged with VEGF injection at 2, 3 and 6
months and were evaluated for leakage. OTX-TKI significantly suppressed
leakage and showed minimal to no vascular leakage through 6 months.
Blank control eyes showed high tortuosity and leakage at all time
points. For the first time, this study demonstrated the ability to
deliver an efficacious dose of TKIs to the posterior segment of the eye
using the OTX-TKI delivery platform, and the potential to serve as an
alternative to the once every 4-6 week injections which are the current
standard of care.

Retinal diseases such as age-related macular degeneration (AMD), retinal
vein occlusion (RVO) and diabetic macular edema (DME) can be devastating
to eyesight, causing central and/or peripheral vision loss. AMD is one
of the most common retinal diseases, affecting more than 2 million
Americans alone, and is the leading cause of blindness in the United
States.

Current therapies for retinal diseases require monthly injections, which
have shown to manage the progression of these diseases to prevent
further vision loss and, in some cases, gain visual acuity. However,
these frequent intravitreal injections can increase the risk of
infection, retinal detachment, and/or hemorrhage.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the
development, manufacturing and commercialization of innovative therapies
for diseases and conditions of the eye using its proprietary hydrogel
platform technology. Ocular Therapeutix’s lead product candidate,
DEXTENZA™ (dexamethasone insert) 0.4 mg for intracanalicular use has
completed Phase 3 clinical development for the treatment of ocular pain
and inflammation following ophthalmic surgery. The FDA has accepted the
Company’s NDA resubmission for DEXTENZA for the treatment of ocular pain
following ophthalmic surgery and has established a PDUFA target action
date of July 19, 2017. If approved, the Company intends to submit a
supplement to its NDA for ocular inflammation. OTX-TP (travoprost
insert) is in Phase 3 clinical development for glaucoma and ocular
hypertension. Ocular Therapeutix is also evaluating injectable drug
delivery depots for back-of-the-eye diseases. Ocular Therapeutix's first
product, ReSure® Sealant, is FDA-approved to seal corneal
incisions following cataract surgery.

Forward Looking Statements

Any statements in this press release about future expectations, plans
and prospects for the Company including the development and regulatory
status of the Company’s product candidates, such as the Company’s
expectations and plans regarding regulatory submissions for and the
timing and conduct of clinical trials of DEXTENZA™ for the treatment of
post-surgical ocular inflammation and pain, including our expectations
regarding the NDA filed with the FDA and the FDA’s response to the
resubmitted NDA, and the potential impact of the re-inspection of
manufacturing operations, DEXTENZA for the treatment of allergic
conjunctivitis, DEXTENZA for the treatment of dry eye disease and OTX-TP
for the treatment of glaucoma and ocular hypertension, the ongoing
development of the Company’s sustained release hydrogel technology, the
potential utility of any of the Company’s product candidates, potential
commercialization of the Company’s product candidates, and other
statements containing the words "anticipate," "believe," "estimate,"
"expect," "intend", "goal," "may", "might," "plan," "predict,"
"project," "target," "potential," "will," "would," "could," "should,"
"continue," and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors. Such forward-looking statements involve substantial
risks and uncertainties that could cause the Company’s clinical
development programs, future results, performance or achievements to
differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include, among
others, those related to the timing and costs involved in
commercializing ReSure® Sealant or any product candidate that
receives regulatory approval, the initiation and conduct of clinical
trials, availability of data from clinical trials and expectations for
regulatory submissions and approvals, the Company’s scientific approach
and general development progress, the availability or commercial
potential of the Company’s product candidates, the sufficiency of cash
resources and need for additional financing or other actions and other
factors discussed in the “Risk Factors” section contained in the
Company’s quarterly and annual reports on file with the Securities and
Exchange Commission. In addition, the forward-looking statements
included in this press release represent the Company’s views as of the
date of this release. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However, while
the Company may elect to update these forward-looking statements at some
point in the future, the Company specifically disclaims any obligation
to do so. These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the date
of this release.

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